Accu-Chek Alpha Monitor & Accu-Chek Glucose Test Strips

• 2 recalls, same reason

  • Terminated Z-0979-05 FDA Unclassified (pre-2012) ·initiated 18 May 2005
  • Terminated Z-0978-05 FDA Unclassified (pre-2012) ·initiated 18 May 2005

  The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards while the meter is waiting for the sample or if the test strip opening has been previously flooded with excess control solution or blood.

510(k) Number

K952875 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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